Evista Drug Uses

Evista is a prescription medicine used by women after menopause to treat or prevent a condition called osteoporosis. You should take calcium and vitamin D along with Evista if you do not get enough calcium and vitamin D in your diet.

How Taken

The recommended dosage is one 60-mg Evista tablet daily, which may be administered any time of day without regard to meals.

Evista Warnings/Precautions

Before taking this medication, tell your doctor if you have a history of blood clots; stroke; cancer; increased triglycerides (a type of fat in the blood); or liver disease. You may not be able to take Evista, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Evista is in the FDA pregnancy category X. This means that Evista is known to cause birth defects in an unborn baby. Do not take Evista if you are pregnant or if you could become pregnant during treatment. It is not known whether Evista passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Evista Missed Dose

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Evista Possible Side Effects

An infrequent but serious side effect of taking Evista is the development of blood clots in the veins. These blood clots can stop blood flow and cause serious medical problems, disability or death. Call your doctor right away if you have or have had any of the following signs of blood clots in the legs, lungs or eyes: leg pain or a feeling of warmth in the calves, swelling of the legs, hands or feet, sudden chest pain, shortness of breath or coughing up blood, sudden change in your vision, such as loss of vision or blurred vision. Most of the side effects of Evista are mild and usually do not cause women to stop taking Evista. The most common side effects of Evista are hot flashes and leg cramps. Hot flashes are more common during the first 6 months after starting treatment. If you have any problems or questions that concern you while taking Evista, ask your doctor or pharmacist for more information.

Evista Storage

Store at controlled room temperature, 20o to 25oC (68o to 77oF); allows excursions between 15o and 30oC (59o and 86oF).

Evista Overdose

Incidents of overdose in humans have not been reported. There is no specific antidote for Evista.

More Information

Before having any surgery, tell your doctor that you are taking Evista. Treatment with Evista may need to be stopped temporarily if you require an extended period of bed rest. Avoid sitting still for long periods of time during travel while taking Evista. Alcohol and cigarette smoking may cause increased bone loss. Discuss with your doctor the use of these products.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Even as Evista (raloxifene) reduced the risk of invasive breast cancer by 44%, compared with placebo, it had a significantly increased relative risk of thromboembolic events -- including fatal strokes -- according to a study of more than 10,000 postmenopausal women.
Evista was associated with a 49% increase in the relative risk of fatal stroke (P=0.05), Elizabeth Barrett-Connor, M.D., of the University of California San Diego and colleagues for the RUTH (Raloxifene Use for The Heart) trial reported in the July 13 issue of the New England Journal of Medicine.
Evista was also associated with a significant increase in risks of venous thromoboembolic events (P=0.02), but as expected Evista was associated with a significant decrease in risk of clinical vertebral fractures (P=0.007).
The 44% decrease in invasive breast cancer risk (P=0.003) among women taking Evista was driven by a highly significant reduction in estrogen-positive breast cancer (P<0.001). Evista did not reduce the risk of estrogen-negative breast cancers (P=0.40).
Women taking Evista also had significantly more hot flushes, leg cramps, and peripheral edema (P<0.001 for all compared with placebo), they wrote.
The RUTH investigators randomly assigned 10,101 postmenopausal women (mean age 67.5) with established coronary heart disease or multiple risk factors for heart disease to either 60 mg of Evista daily or placebo. The women were followed for a median of 5.6 years. The primary endpoints were coronary events and invasive breast cancer.
In this group of women at high risk for coronary events, "the difference in absolute rates of events that were decreased (i.e., breast cancer and clinical vertebral fractures) was similar to the difference in the absolute rates of events that were increased (i.e., venous thromboembolic events and fatal strokes)," the authors wrote.
And that may be the sticking point for many clinicians counseling women, said Steven Nissen, M.D., acting director of cardiology at the Cleveland Clinic.
"When a drug increases cardiovascular risk, we have to take that seriously," he said adding that Dr. Barrett-Connor and colleagues did an excellent job of "laying out the risks and benefits very clearly, with no spin."
Dr. Nissen, who was an early critic of Vioxx (rofecoxib) because of its increased risk of thromboembolic events, said that results of the RUTH trial are likely to spur debate if Lilly, the maker of Evista, seeks FDA approval for Evista for breast cancer prevention.
Currently the drug is approved for treatment and prevention of osteoporosis in postmenopausal women.
Earlier this year, results of the STAR (Study of Tamoxifen and Raloxifene) trial indicated that Evista is as effective as tamoxifen for preventing breast cancer in postmenopausal women. Tamoxifen is the only FDA approved drug for prevention of breast cancer.
Lilly said in June that it plans to ask the FDA to approve Evista for cancer prevention.
Evista and tamoxifen are both selective estrogen receptor modulators, or SERMs. SERMs were originally developed as alternatives to estrogen to treat symptoms of menopause as well as osteoporosis. But unlike estrogen, SERMs do not reduce vasomotor symptoms, although they have demonstrated efficacy in osteoporosis.
When the RUTH trial began recruiting women in 1998 it was widely believed that estrogen reduced the risk of coronary events, which led Dr. Barrett-Connor and colleagues to hypothesize that Evista would also be cardio-protective. But in 2002, investigators for the Women's Health Initiative reported that estrogen increased the risk of stroke and thromboembolic events, as well as increasing the risk of breast cancer.
The RUTH results "now allow us to say that all modulators of the estrogen receptors potentially increase the risk of cardiovascular events," said Dr. Nissen.
John T. Cole, M.D., medical director of hematology and oncology services at the Ochsner Health System in New Orleans, said that the RUTH findings coming on the heels of the STAR trial confirm that Evista has a role in chemoprevention in a select population -- but defining that population may be difficult.
Even so-called high risk women only have very small absolute risk for developing breast cancer, he said. "If you look at in terms of telling a woman that she has about a 98.4% chance of [not developing breast cancer], it is difficult to imagine her wanting chemoprevention," he said.
Nonetheless, Dr. Cole said that in both the RUTH trial and the STAR trial "as risk increased, so did the potential benefit of chemoprevention."
In an NEJM editorial, Marcia L. Stefanick, Ph.D., of the Stanford Prevention Research Center in Stanford, Calif., said the RUTH study "highlights the need to consider the risk of breast cancer as well as other risks and coexisting conditions in determining whether and when [Evista] or another SERM is warranted for an individual woman."
"For women represented by the RUTH cohort of women with or at increased risk for CHD, the moderate benefits of raloxifene for breast cancer prophylaxis do not seem to justify the risks" she wrote.
"For now," Dr. Stefanick continued, "there is no magic bullet that can reduce the risks of major health problems related to estrogens and aging without introducing other potentially serious health concerns."

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